House subcommittee weighs patent reforms to speed generics after same‑day Supreme Court ruling

Chairman Issa opened a subcommittee hearing on pharmaceutical and biotechnological patents, saying the panel would focus on patent law rather than FDA processes or reimbursement. "For decades, The United States has led the world both in original innovations and in generic development," he said, while flagging concerns about duplicative filings and recent changes at the Patent Trial and Appeal Board.

The hearing brought four witnesses who framed the clash over how to balance incentives for drug discovery with faster patient access. Krista Carver of Covington and Burling told the committee that U.S. policy choices such as the Hatch‑Waxman Act and the Biologics Price Competition and Innovation Act have historically encouraged both innovation and competition. "We should be thoughtful about proposals that seek to change this careful balance," she said, urging Congress to avoid measures that would force innovators to relinquish valid rights.

Jamie Simpson of the Council for Innovative Promotion likewise praised the existing dispute‑resolution framework and warned that sweeping reforms could erode incentives that draw biopharma investment to the United States.

By contrast, Rachel Goode of Fresenius Kabi, which she said employs more than 4,000 people in the U.S. and has invested over $1,000,000,000 in U.S. manufacturing, described how what she called "duplicate" or terminally disclaimed continuation patents can be used to delay generics and biosimilars. Goode endorsed the Ethic Act as a targeted reform that would limit serial litigation over essentially equivalent claims and speed lawful competition to market.

Professor Michael Carrier of Rutgers said empirical patterns show a spike in continuation patents timed to coincide with the expiry of regulatory exclusivity, and he argued the Ethic Act would curb that practice. Carrier also noted a unanimous Supreme Court decision released that morning on skinny‑label pleadings; he said the ruling was favorable but that statutory clarity from Congress could provide more durable certainty.

Members pressed witnesses on several technical points. Witnesses disagreed about whether terminal disclaimers are mainly a useful prosecution tool or an avenue for gamesmanship; Simpson called some characterizations an oversimplification, while Goode and Carrier cited peer‑reviewed analyses and examples of repeated litigation that can stretch for years. The witnesses also debated how many years of effective market exclusivity drugs typically experience, with panelists citing figures ranging from roughly 12–14 years up to more recent data showing longer delay patterns for some biologics.

Several members, including Rep. Zoe Lofgren, emphasized patient affordability concerns and supported codifying a safe harbor for skinny labels to protect generics that lawfully carve out patented uses. Other members, and some witnesses, warned that statutory carve‑outs should be narrowly written to preserve incentives for discovering new uses and formulations.

The hearing closed with the chair placing a set of stakeholder letters and studies in the record by unanimous consent and giving members five legislative days to submit follow‑up questions. No formal votes were taken.

The committee provided a forum for sharply divergent views: industry and some legal scholars defended existing protections as central to continued R&D, while generic and biosimilar advocates argued targeted patent‑quality and litigation reforms would accelerate access and lower patient costs. The subcommittee said it will consider legislation and follow up with written questions for witnesses.